FirstResponseHIV1-2.O Cardtest,V2, kit/5

General description:
First Response HIV 1-2.O Card Test (Version 2.0) is a rapid, immunochromatographic, qualitative screening, in vitro diagnostic test for detection of antibodies specific to HIV-1 (including Group O) and HIV-2 in human serum, plasma or venous and capillary whole blood. The test can be used as an aid in the diagnosis of HIV-1 and HIV-2.

Technical specifications:
Technology: Lateral flow immunochromatographic assay
Sample type: Venous and capillary whole blood, serum, plasma
Clinical sensitivity: 100%
Clinical specificity: 100%
Time to result: Interpret the test result at 15 minutes after adding assay buffer. Do not read test result after 25 minutes.

Manufacturer product reference: Premier Medical Corporation Private Limited, PI05FRC05

Items supplied with:
·Test device pouch containing: 1 test device and 1 desiccant,5
·Specimen transfer device, 5
·Assay buffer bottle (2.5 ml), 1
·Sterile non-safety lancets, 5
·Alcohol swabs, 5
·IFU, 1

Items required, but not supplied:
New pair of disposable gloves, face mask, sterile gauze pad, pen, timer, extra lancets, alcohol swabs and specimen transfer devices, if needed, sharps disposable box, venipuncture blood collection kit (if whole blood is collected by venipuncture), biohazardous waste container

Shelf life:
24 months from the date of manufacturing; do not use beyond its expiry date.

Weight & volume:
Estimated weight: 0.0837kg
Estimated volume: 0.00037m3

Storage & transportation condition:
The test kit should be stored at 4 to 30°C. Do not freeze.

Packaging & labelling:
Primary packaging: All contents of First Response HIV 1-2.O Card test (Version 2.0) for 5 tests
Secondary packaging: One kit First Response HIV 1-2.O Card test (Version 2.0), 5 tests

General recommendations:
·Follow strictly manufacturer instructions for use of the test procedure (especially adherence to reading time).
·Do not use any other specimen than those specified.
·Apply standard biosafety precautions when handling and disposing of potentially infectious material.
·Do not use if any kit components are damaged.
·Do not mix reagents from different lots.

Useful links:
WHO PQ Public report